Complaint Investigator

Job Title: Complaint Investigator / Reviewer 

Analyze complaint data and apply appropriate coding to complaint records, linking complaints to product improvements, product defects, and safety evaluations 
Perform independent technical assessment on product quality complaints and post-market product quality analysis 
Evaluate complaint data and confirm regulatory reportability decisions and risk assessments performed 

Experience: 
5 years’ experience 
Bachelor’s degree in biomedical sciences, or other technical degrees 
Working knowledge of appropriate global medical device regulations, requirements, and standards such as ISO 13485 and ISO9001, and FDA QSR. Medical Device and or other regulated industry (Pharma, IVD,) preferred. 
An organized, analytical thinker with exceptional attention to detail 
Experience in Complaint Handling and/or Symptom Coding

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